The home uterine activity monitor (HUAM) is a device intended to provide early detection of preterm labor (PTL) in women at high risk of developing PTL and preterm birth (PTB). The monitoring device consists of a guard-ring tocodynamometer (worn as a belt around the abdomen), a data recorder, and a data transmitter. Usually, the patient is instructed to use the device daily for two 1-hour periods. After monitoring, the patient is supposed to transmit the recordings by telephone modem link to a remote base station. Base station nurses not only facilitate transmission and analysis of the monitor tracings, they also maintain daily telephone contact with the patient to assess signs and symptoms and to provide advice and counseling.

Nurses employed in HUAM services look for evidence of the onset of PTL, either on the basis of uterine activity exceeding a threshold level or from the findings of a telephone interview with the patient. Signs and symptoms of PTL include back pain, increased vaginal discharge, menstrual-like cramps, and pelvic pressure or heaviness. The threshold number of uterine contractions signaling the possible onset of PTL is usually 4 to 6 per hour. If signs and symptoms are present or the uterine activity exceeds a certain threshold, patients are instructed to perform the following: empty the bladder, hydrate orally, and assume the left lateral recumbent position. The patient is also instructed to remonitor for one additional hour. If uterine activity still exceeds threshold or signs and symptoms persist, the patient is instructed to see her physician immediately for a cervical examination. The cervical examination would then play a pivotal role in diagnosing whether PTL is occurring and whether to initiate tocolytic therapy.

In March 2001, the U.S. Food and Drug Administration (FDA) reclassified HUAMs from class III (Premarket Approval) to class II (Special Controls) devices. The HUAM is a post-amendment device and thus, was automatically reclassified into class III. Devices with 510(k) marketing clearance from the FDA include the Fetal Assist (Huntleigh Diagnostics, Eatontown, NJ) and the Carefone Home Uterine Activity Monitoring System (Carelink Corp, Santa Ana, CA). The HUAM is described as an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic. The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. The FDA indicates that the device is intended for use in women at least 24 weeks’ gestation with a previous preterm delivery to aid in the detection of preterm labor.

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

4/25/2008: Based on the accumulating evidence that home uterine activity monitoring does not accurately predict preterm labor or improve health outcomes, the policy statement was changed to state that home monitoring is considered not medically necessary. (previously this was investigational)